Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke：Longterm Outcome (OPENS-3L)

• Status: Recruiting
• Trial end date: 2025-10-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the long-term efficacy and safety of Normobaric Hyperoxia combined with intravenous thrombolysis for acute ischemic stroke.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ji Xunming,MD,PhD
• Collaborators: Affiliated Hospital of Nantong University; Beijing Friendship Hospital; Beijing Shijitan Hospital, Capital Medical University; Beijing Tongren Hospital; Changsha Central Hospital; Guizhou Provincial People's Hospital; Jining First People's Hospital; Linyi People's Hospital; Nanyang Central Hospital; People's Hospital of Beijing Daxing District; Rizhao People's Hospital; Second Affiliated Hospital of Nanchang University; Shandong Provincial Hospital; The Affiliated Hospital of Xuzhou Medical University; The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Zhengzhou University; The Second Hospital of Anhui Medical University; Tianjin Huanhu Hospital; Zhumadian Central Hospital

Criteria

Inclusion Criteria:

1. Age≥18 years;

2. The time from onset to randomization is within 4.5 hours of onset;

3. The clinical diagnosis is acute ischemic stroke (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);

4. Baseline NIHSS (at the time of randomization) should be ≥5 and ≤25 points;

5. Pre-stroke mRS score≤1 points;

6. Informed consent from the patient or surrogate.

Exclusion Criteria:

1. Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);

2. Past history of intracranial hemorrhage;

3. Rapid neurological function improvement, NIHSS score less than 5 points;

4. Presence of proximal arterial occlusion on computed tomography angiography(CTA)/magnetic resonance angiography(MRA) (e.g., intracranial internal carotid artery(ICA), middle cerebral arterial(MCA)-M1, and vertebrobasilar arteries);

5. Massive anterior cerebral infarction identified by CT or MRI (ASPECT < 6 or lesions larger than one third of the territory of the middle cerebral artery);

6. Intended to proceed endovascular treatment;

7. Pregnant women, or planning to become pregnant during the trial;

8. A history of severe head trauma or stroke within 3 months;

9. A history of intracranial or spinal surgery within 3 months;

10. A history of gastrointestinal or urinary bleeding within 3 weeks;

11. two weeks of major surgery;

12. Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week;

13. Active visceral bleeding;

14. Intracranial tumors, large intracranial aneurysms;

15. Aortic arch dissection was found;

16. Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg);

17. Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol);

18. Oral warfarin anticoagulant with international normalized ratio(INR)>1.7 or PT>15 s;

19. Heparin treatment was received within 24 h;

20. Thrombin inhibitors or factor Xa inhibitors were used within 48 h;

21. Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise;

22. Hereditary or acquired bleeding constitution;

23. Onset with seizures;

24. Severe liver and kidney dysfunction;

25. Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;

26. Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;

27. Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen;

28. Life expectancy < 1 year;

29. Patients who could not complete the 90-day follow-up;

30. Participation in other clinical trials within 3 months prior to screening;

31. Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.